# K101113: Guardian II NC Hemostasis Valve

- Pathway: 510(k) (Special)
- Applicant: Zerusa Limited
- Decided: May 21, 2010 after 30 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K854261 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092711: Guardian II Hemostasis Valve, Zerusa Limited (2009) Summary page 1.

## Recalls of this device
- Feb 27, 2013 · Class I · Z-0955-2013: Risk that air may be introduced into the device which may lead to an air embolism.
- Aug 30, 2012 · Class II · Z-2400-2012: Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of pro

## Indications for use
The Guardian® II NC HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian® II NC HV. The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.

Source page: https://510kreport.com/device/K101113
Methodology: https://510kreport.com/methodology